Effects of Semi-standarized Acupuncture in Chronical Symptomatic Osteoarthritis of the Knee Through: A Randomized Controlled Trial

NCT05096806 | Unknown DMC

• 1 other identifier: CEBRU0021-21
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

Introduction: Knee osteoarthritis is a long-term rheumatic disease with a significant impact on the patient's quality of life and the socio-economic development of societies. The usual treatment consists of non-steroidal anti-inflammatory drugs as a palliative measure. The decrease in the beneficial effect and the appearance of serious long-term adverse effects make it necessary to look for other therapeutic procedures. Acupuncture is a non-pharmacological treatment that could reduce pain and improve functionality in this condition, however current scientific evidence is limited. A previous study has observed a clinical improvement in the combination of sensitized local and peripheral points in the treatment of knee osteoarthritis but studies with a larger sample are needed to confirm these results. Objective: Assess the effectiveness of acupuncture using a combination of local and peripheral sensitized points in the treatment of active knee osteoarthritis. Methods: A randomized clinical trial will be performed in a hospital centre with 2 groups. The control group will standard treatment plus transcutaneous electrical nerve stimulation, while the intervention group will receive acupuncture in addition to standard care. Study outcomes will be pain, quality of life, function, exercise adherence, drug intake, adverse effects, and body mass index. There will be a 12-month post-intervention follow-up.

Conditions

Osteoarthritis, Knee

Keywords

Acupuncture; Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (3)

• Change from Baseline Pain at post intervention

  Pain will be assessed using the visual analogue scale (VAS)

  At the end of the intervention, at the 4th week of the study

• Change from Baseline Knee function at postintervention

  Knee function will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  At the end of the intervention, at the 4th week of the study

• Change from Baseline Quality of life at postintervention

  Quality of life will be assessed using the SF-12 questionnaire. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.

  At the end of the intervention, at the 4th week of the study

Secondary Outcomes (5)

• Change from Baseline Pain at 4 months

  16 weeks afther the end of the intervention, at the 20th week of the study

• Change from Baseline Knee function at 4 months

  16 weeks afther the end of the intervention, at the 20th week of the study

• Change from Baseline Quality of life at 4 months

  16 weeks afther the end of the intervention, at the 20th week of the study

• Drug intake postintervention

  through study completion, an average of 1 year

• Adverse events postintervention

  through study completion, an average of 1 year

Study Arms (2)

Usual care plus TENS

ACTIVE COMPARATOR

Participants in this group will receive transcutaneous electrical nerve stimulation (TENS) and usual care. TENS treatment will perform in the region of the knee and the extensor muscles for 20 minutes, 2 times a week. 4 electrodes will be placed, 2 on the proximal region of the internal and external vastus, and the other 2 on the distal region of the motor plate. Usual care will consist in home exercises with toning exercises of the extensor apparatus, pelvic region and musculoskeletal stretching exercises of 2 weekly sessions, the recommendation of daily activity of walking for 1 hour daily as an active lifestyle and the recommendation of the reduction of body weight in the case of being above normal weight. There will be a total of 6 face-to-face sessions at the rate of 2 weekly sessions

Device: TENS

Usual care plus Acupuncture

EXPERIMENTAL

Participants in this group will receive acupuncture treatment and usual care. Acupuncture treatment will consist in 20-minute semi-standardized acupuncture sessions, 2 times a week. The intervention will consist of the insertion of 8 needles: 4 in points located in the knee (points St34, St35, XiYan and Sp10) and 4 more sensitive to palpation points located between the knee and the ankle. Stimulation will be performed to obtain local spasm response, the needles will be left for 20 minutes and then removed. The needles will be sterile disposable silicone needles of 0.20x20mm and 0.20x40mm. Usual care will be the same described in the Usual care plus TENS group

Other: Acupuncture

Interventions

Acupuncture OTHER

Acupuncture is a non-pharmacological technique that consists in the stimulation of specific points located in the skin surface. Points are stimulated by piercing the skin with fine needles.

Usual care plus Acupuncture

TENS DEVICE

TENS is a therapy that uses low voltage electrical current to provide pain relief. A TENS unit consists of a battery-powered device that delivers electrical impulses through electrodes placed on the surface of your skin. The electrodes are placed at or near nerves where the pain is located or at trigger points.

Also known as: Transcutaneous electrical nerve stimulation

Usual care plus TENS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Usual painful episode of 3 months or more
• Morning stiffness of 15 minutes or more
• Pain equal to or greater than 5 on the VAS
• Grade 2 or greater on the Kellgren-Lawrence scale

You may not qualify if:

• Corticosteroid infiltration in the 3 months prior to recruitment
• Rehabilitation treatment one month prior to recruitment
• With a knee prosthesis
• Needle phobia
• Pregnancy
• With pacemakers
• Cardiac arrhythmias

Sponsors & Collaborators

• Universitat de Girona: lead

Related Publications (5)

• Roos EM, Arden NK. Strategies for the prevention of knee osteoarthritis. Nat Rev Rheumatol. 2016 Feb;12(2):92-101. doi: 10.1038/nrrheum.2015.135. Epub 2015 Oct 6.

  PMID: 26439406 BACKGROUND

• Vickers AJ, Vertosick EA, Lewith G, MacPherson H, Foster NE, Sherman KJ, Irnich D, Witt CM, Linde K; Acupuncture Trialists' Collaboration. Acupuncture for Chronic Pain: Update of an Individual Patient Data Meta-Analysis. J Pain. 2018 May;19(5):455-474. doi: 10.1016/j.jpain.2017.11.005. Epub 2017 Dec 2.

  PMID: 29198932 BACKGROUND

• Woods B, Manca A, Weatherly H, Saramago P, Sideris E, Giannopoulou C, Rice S, Corbett M, Vickers A, Bowes M, MacPherson H, Sculpher M. Cost-effectiveness of adjunct non-pharmacological interventions for osteoarthritis of the knee. PLoS One. 2017 Mar 7;12(3):e0172749. doi: 10.1371/journal.pone.0172749. eCollection 2017.

  PMID: 28267751 BACKGROUND

• Cao H, Bourchier S, Liu J. Does Syndrome Differentiation Matter? A Meta-Analysis of Randomized Controlled Trials in Cochrane Reviews of Acupuncture. Med Acupunct. 2012 Jun;24(2):68-76. doi: 10.1089/acu.2011.0846.

  PMID: 24761164 BACKGROUND

• Li J, Li YX, Luo LJ, Ye J, Zhong DL, Xiao QW, Zheng H, Geng CM, Jin RJ, Liang FR. The effectiveness and safety of acupuncture for knee osteoarthritis: An overview of systematic reviews. Medicine (Baltimore). 2019 Jul;98(28):e16301. doi: 10.1097/MD.0000000000016301.

  PMID: 31305415 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Acupuncture Therapy; Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Central Study Contacts

Tomás Tegiacchi

CONTACT

0034676364399; tomasjtg@gmail.com

Carles Fernández

CONTACT

0034651503494; carlesfj@blanquerna.url.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 27, 2021
• Study Start: January 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2024
• Last Updated: October 27, 2021

Record last verified: 2021-10